KR102538262B1 - Implant for stabilizing fractured or non-fractured bones - Google Patents

Abstract

A bone implant (1) for stabilizing fractured or non-fractured bone comprises an implant body (2) extending along a longitudinal axis (3) from an anterior side (4) to an end side (5); It preferably includes a cylindrical body. The implant body 2 has an implant width 6 extending perpendicular to the longitudinal axis 3, the length of the implant body 2 along the longitudinal axis 3 being at least 5 of the implant width 6. It is a ship. The implant body 2 has an outer surface divided into at least a first surface 7 and a second surface 8 . The first surface 7 consists of a holding area 9 extending at least partially over said outer surface, preferably over half of the outermost surface.

Description

Implant for stabilizing fractured or non-fractured bones {IMPLANT FOR STABILIZING FRACTURED OR NON-FRACTURED BONES}

The present invention relates to bone implants for stabilizing fractured or non-fractured bone, uses of implants and methods thereof according to the independent claims.

Bone implants are widely used to stabilize fractured bones.

For example, US 2009/0157078 discloses a cannulated screw that repairs defects in the humerus or femur. Some of the screws do not contain threads, but rather holes that allow cement to be introduced into cavities in the bone. The device includes a screw head on one side of the implant, requiring the screw to extend partially out of the bone. The other end of the implant is threaded so that the screw is secured only if it can be anchored into the bone on the opposite side of the screw head. Such implants are limited in their applications.

WO 2012/142032 discloses a method and apparatus for bone preparation. The device includes an insert structure having perforations through which fluid can be introduced into the bone. The device can be used for internal fixation of fractures or possibly implanted into weak and/or cancerous bones. The fluid may be bone cement. The implant part of the device is anchored to the outside of the bone and is very complex. Moreover, multiple implants are used in one bone, weakening the bone tissue due to the number of introduction channels.

WO 2012/066236 relates to a device for combining two intersecting implants for the prophylactic or curative treatment of fractures of the femur. Such cross implants are fixed relative to each other, thereby preventing any movement of the implants. Such a device can only be applied to bones where it is possible to intersect the implant.

Accordingly, the object of the present invention is to eliminate the problems of the prior art, a bone implant for stabilizing a fractured or non-fractured bone, which can be used for multiple purposes in different bones of the human body and capable of stable positioning inside the bone, the use of the implant, and It's about providing that way.

The above object is achieved by a bone implant for stabilizing fractured or non-fractured bone comprising an implant body, which is preferably a cylindrical body. The implant body extends along a longitudinal axis from the anterior side to the distal side. The implant body has an implant width extending orthogonally to the longitudinal axis, and the length of the implant body along the longitudinal axis is at least five times the implant width. The implant body has an outer surface divided into at least a first surface and a second surface, the first surface consisting of a fixation region extending at least partially over the outer surface, preferably over half of the outer surface.

A fixation area according to the present invention comprises a surface that improves fixation of the implant when implanted into bone. Bone tissue can more easily grow into the implant, so that the anchoring of the implant is improved.

Such implants are easily introduced and anchored into bone, particularly into the spine. The anchoring region is preferably located at the proximal end of the implant when implanted in bone.

The implant body preferably has a constant implant width across at least the first and second surfaces. Moreover, the implant does not include an extension at the proximal end, such as a screw head for example. Thus, preferably the implant width is constant over at least the first and second surfaces, while the implant width in other areas may only be smaller.

The first and second surfaces preferably each extend through 360° along and about the longitudinal axis.

The implant may comprise a bore extending along or parallel to a longitudinal axis and having at least one, preferably two, openings on the anterior side and/or on the distal side.

The bore in the bone implant makes the implant lighter and in the case of two openings offers the possibility of fluid introduction into the bone.

The length of a bone implant can range from 10 mm to 250 mm.

Certain bone implants can be used for different bones and still have the length needed to stabilize each bone.

The width of the bone may range from 5 mm (for the ribs) to 50 mm (for the femoral diaphysis) or 80 mm (for the humerus head). The width of the bone implant may range from 2 mm to 10 mm.

Such bone implants can be readily introduced into bone without destroying other bone tissue and yet deliver sufficient stability to serve their purpose of stabilizing bone.

The outer surface, preferably the second surface, includes a hole having a wall around the hole axis.

On the other hand, a bone implant having a hole on its outer or second surface, respectively, on the one hand, provides the possibility of bone tissue growth into the hole, thereby improving the positioning of the implant, and in the case of a bone implant with a bore, the implant into which the hole is located. It provides the possibility of guiding fluid into the bone tissue around the part of the body.

The fluid is preferably bone cement, such as PMMA bone cement, bio-resorbable bone cement, or any other product that allows anchoring of the implant to bone.

The holes may have a diameter of 0.2 mm to 5 mm on the outer or second surface, respectively.

Through such a hole, bone tissue can grow quickly, and a fluid such as bone cement can be easily introduced into the bone.

The wall of the hole may have a cylindrical, preferably conical shape.

Cylindrical bores are easy to manufacture and can lower their manufacturing costs, while the conical shape optimizes the distribution of fluid introduced into the bone through the bone implant.

The implant may include a first set of holes, wherein hole axes of the first set of holes are disposed substantially orthogonal to the longitudinal axis.

A set of holes may include one or more holes.

A hole with the hole axis disposed perpendicular to the longitudinal axis allows fluid to be distributed through the hole radially away from the implant, so that the bone cement reaches as far as possible.

The implant may include a second set of holes, the hole axis of the second set of holes being inclined with respect to the longitudinal axis, preferably at an angle greater than 90° and less than 150° with respect to the longitudinal axis. .

The inclined hole axis allows distribution of fluid to a specific point inside the bone when the implant is placed inside the bone.

The implant may include a third set of holes, the hole axis of the third set of holes being inclined with respect to the longitudinal axis at a different angle than the hole of the second set, preferably 90° to the longitudinal axis. It is smaller than 30° and slopes at an angle greater than 30°.

The inclined hole axis allows distribution of fluid inside the bone to a specific area when the implant is already located inside the bone. In addition, the inclined hole enables the introduction of bone cement even in sensitive areas of the nerve since it is possible to direct the flow of cement to a specific area.

In particular, the combination of the first, second and third sets of holes makes it possible to direct fluid from inside the implant to a specific area of the bone for that implant.

The apertures may be substantially uniformly distributed in an area over 360° about the longitudinal axis in the outer or second surface, and preferably the spacing between adjacent apertures in a row is substantially may be distributed in rows along the longitudinal axis such that .

Such an arrangement allows for optimized distribution of fluid and uniform distribution of tissue growth into the implant.

The apertures may be disposed in a region spanning from 180° to 270° about a longitudinal axis in the outer or second surface, preferably such that adjacent apertures within a row are substantially equally spaced. It can be distributed in rows along the axis.

The placement of the holes in an area spanning 180° to 270° around the longitudinal axis offers the possibility of guiding fluid through the implant only to those parts of the bone that require fluid.

The first hole in the first row and the first hole in the second neighboring row may have different distances from the front side, preferably the difference in distance between the two neighboring holes in one row. equal to half the distance

Such a distribution of neighboring holes in neighboring rows provides an optimized distribution of fluid introduced through the implant into the bone.

The distribution of the holes preferably does not compromise or significantly compromises the stability of the implant, and nevertheless the distribution of the fluid is chosen to be optimized for the particular situation. In the case of the spine, a hole will be placed in the distal part of the implant to be implanted in the vertebral body, the hole into which cement can be injected at 270° to 300° around the longitudinal axis, end plate fractures ( It can be arranged not to be injected into the upper endplate side to avoid leakage in case of end-plate fracture.

In the humeral bone application, the holes are placed throughout the implant over 360° about the longitudinal axis, allowing 360° of cement flow. This allows for good implant fixation, bone reinforcement and complete filling of the tumor if applicable.

The fixation area may include means for improving the fixation of the implant within the bone, preferably surface structures and/or roughnesses and/or depressions.

The surface structure may be a groove, thread or ring structure, while the thread or groove pitch or ring structure may be a square, symmetrical triangle or asymmetrical triangle. Alternatively or additionally, the surface structure may include rectilinear or helical concavities or may include cross-shaped or diamond-shaped pitches. The concave portion of the fixing area may have a depth of 0.5 mm to 3 mm.

All depth values according to the present invention are measured from top to bottom. Of course, statistical deviations may occur.

The surface structure improves the fixation of the implant.

The roughness can vary from 1 μm to 0.5 mm.

The fixing area may comprise groove-like surface structures, preferably six or eight grooves, substantially uniform and arranged about the longitudinal axis and extending coaxially along the longitudinal axis.

The groove may have the same shape and/or height as the concave and/or threaded or ring-shaped surface structure.

The use of a groove-like surface structure improves the fixation of the implant, thus making it more durable and secure.

The fixing area may include a surface structure in the form of a screw thread or a ring-shaped groove. Such fixation zones improve fixation of the implant within the bone.

The cross section of the groove may be U-shaped, V-shaped or square. By such a groove, surface contact between the bone and the implant is increased and stress concentration in the bone is suppressed. It is also possible to stabilize the implant against rotation prior to injection of the cement, which is important for example in the case of spinal implants where the injection hole must have a certain orientation. After implantation of the cement, stabilization of the implant, for example against rotational and translational movements, is performed by the cement.

The implant may include a fixed connector that enables retention of the implant during introduction into the bone.

The anchoring connector may for example be a thread allowing connection of a bone implant to a tool. The anchoring connector is preferably threaded inside the bore of the bone implant, which internal thread preferably has a larger diameter than the rest of the bore to improve easy introduction of the tool. With such an internal thread, the outer surface can be optimized for fixation of the implant inside the bone.

Additionally, fluid can be introduced through the tool and implant when connected by a fixed connector. This provides for easy handling of the implant when introducing and securing the implant.

The outer surface may include a third surface at least partially conically shaped. Such a third surface is disposed on the opposite side of the anchoring surface, providing the possibility of easier introduction of the bone implant into the bone.

The implant can be made of any implantable material, such as PEEK, titanium, stainless steel, Nitinol or combinations thereof.

The above object is also achieved by the use of an implant as described above in restoring fractured bone.

The above object is also achieved by the use of an implant as described above in preventing bone fractures.

The fractured bone may be, for example, a humeral head or diaphysis, a heel bone, a wrist radius, a shin bone, a pelvic bone or a rib. For example, applications for preventing bone fractures are, for example, the humerus, ribs or vertebral body when severe osteoporosis or lytic lesion tumors have been induced.

The above object is also achieved in a method for stabilizing a fractured or non-fractured bone by inserting a bone implant as described above into a bone, preferably introducing bone cement into the bone through the bone implant.

Such a method provides easy introduction and fixation of the bone implant within the bone without the need for any plate or additional fixation means.

Hereinafter, embodiments of the present invention will be described with reference to the drawings.
1 is a bone implant of a first embodiment;
2 is a first cross-sectional view of a bone implant of a second embodiment;
3 is a cross-sectional view of a bone implant of a third embodiment;
4 is a bone implant of a fourth embodiment;
5 is a cross-sectional view of the bone implant according to FIG. 4;
6 is a bone implant of a fifth embodiment;
6a to 6c are detailed views of FIG. 6;
7 is a cross-sectional view of a bone implant of a sixth embodiment;
8 shows two bone implants stabilizing a fracture site in the spine;
9 shows two implants according to a third embodiment for stabilizing a fracture site in the spine;
10 is a bone implant according to a first embodiment for stabilizing the humerus bone.

1 shows a bone implant 1 according to a first embodiment. Bone implant 1 comprises an implant body 2 having a longitudinal axis 3 . This implant body (2) comprises a front side (4) and an end side (5). Additionally, the implant body 2 is divided into a first surface 7 and a second surface 8 . The first surface 7 comprises a fixation area 9 which improves the fixation of the implant in the bone. Perpendicular to the longitudinal axis, the implant body 2 comprises an implant width 6 . The implant width 6 is constant along the first surface 7 and the second surface 8 and is no greater than at any other point on the implant 1 . The second surface 8 comprises a hole 12 and a bore 10 inside the implant body 2 . Hole 12 allows fluid, such as bone cement, to be introduced into the bone through implant 1, optimizing the fixation of implant 1 within the bone due to the growth of bone tissue into hole 12. . The implant body 2 further comprises a third surface 17 which also has a conical shape. At the third surface, the width of the implant is reduced to facilitate easier introduction of the implant 1 into the bone. The anterior side 4 of the implant body 2 is rounded to form a hemispherical shape to facilitate the introduction of the implant 1 into the bone. The fixation area 9 of the first surface 7 comprises a surface structure that improves the fixation of the implant 1 in the bone. The holes are distributed over 360° around the implant body 2, and the holes 12 are arranged in rows. The rows are offset relative to each other such that the first apertures 12 of a first row 18 have a different distance from the front side 4 than the first apertures 12 of a neighboring second row (not shown). do. The length of the implant body is 100 mm, while the width of the implant is 5 mm. The diameter of the hole 12 is 2.5 mm. The wall of hole 12 has a cylindrical shape.

For example, those values for a standard spinal implant are 50 mm to 85 mm in length, preferably 70 mm on average, 4 mm to 7 mm, preferably 5 mm in diameter, and 1 mm to 3 mm bore. , preferably 2 to 2.5 mm.

Figure 2 shows a cross-sectional view taken through a second embodiment of the present invention. In this embodiment, the implant body 2 comprises a bore 10 along its longitudinal axis. On its end side 5, a fixing connector is arranged to enable connection of the implant body 2 with an insertion tool (not shown). Unlike the first embodiment of FIG. 1 , the apertures 12 of the second embodiment are arranged over the larger second surface 8 compared to the smaller first surface 7 . The first set of holes 12 comprises hole axes 11a arranged perpendicular to the longitudinal axis 3 . The second set of holes comprises an inclined axis 11b, the inclination of which is 120° relative to the longitudinal axis 3. The anterior side 4 also includes a third surface 17 that facilitates insertion of the implant into the bone.

3 shows a cross-sectional view of a third embodiment of the present invention. In this embodiment, the bore 10 comprises a threaded anchoring connector 16 on the end side 5 of the implant body 2 . By means of its thread, the tool can be secured to the implant. The apertures 12 are disposed at 270° about the longitudinal axis 3, so fluid, such as bone cement, is directed only 260° away from the implant. In this way, sensitive areas will not be filled with fluid or bone cement.

4 shows a fourth embodiment of the present invention. This embodiment corresponds to the first embodiment in FIG. 1 except that the first surface 7 comprises a holding area 9 . The fixation area 9 comprises a screw thread, the pitch of which extends from the implant width 6 . Such a fixation area improves fixation of the implant within the bone. Moreover, the third surface 17 in this embodiment is shorter compared to the embodiment of FIG. 1 , whereby the conical shape of the second surface 17 comprises a steeper slope compared to the embodiment of FIG. 1 . Additionally, the front side 4 is more pointed compared to the embodiment of FIG. 1 .

FIG. 2 shows an embodiment as shown in FIG. 3 , wherein the first surface 7 comprises a threaded fastening area. The fixing area 9 in this embodiment corresponds to the fixing area 9 in FIG. 4 .

6 shows an embodiment of an implant 1 comprising a first surface 17 with a longitudinal groove 13 . The longitudinal groove 13 improves the fixation of the bone implant within the bone. The longitudinal groove may have a square cross-sectional shape to prevent rotation (see Fig. 6a), or a hemispherical shape to facilitate insertion and better bone contact compared to a square shape or other angular shapes (see Fig. 6b). ), and may include a triangular shape to maximize surface contact (see Fig. 6c). In the embodiment according to FIG. 6 the hole 12 is arranged only over 270° to 300° around the implant.

7 shows a sectional view of the embodiment according to FIG. 6 . The bore 10 along the longitudinal axis 3 contains a fastening connector 16 enabling a threaded connection to a tool (not shown). Holes 12 are disposed along three different hole axes 11a-11c. The first hole axis 11a is disposed perpendicular to the longitudinal axis. The hole axes 11b for the second set of holes are arranged at 130° to the longitudinal axis 3 . The hole axis 11c for the third set of holes is disposed at 60° to the hole axis. Such a hole arrangement is particularly suitable for implants in the spine in that the bone cement introduced through bore 10 and hole 12 is optimally distributed in the spine. Its purpose is to avoid the risk of leakage anteriorly or posteriorly through the wall of the vertebral body which may have been damaged by a fracture.

8A-8C show exemplary embodiments of the use of implants in the spine. 8A shows a top view of the spine with two implants introduced for stabilization of the spine, FIG. 8B shows its side view and FIG. 8C shows its rear view. The implant introduced in this embodiment is the implant according to FIG. 1 .

9a to 9c are views identical to those of FIG. 8 applying the embodiment of the implant according to FIG. 4 .

10 shows an implant 1 used as an implant for stabilization in the humerus. The humerus was not fractured. Nevertheless, the implant 1 is introduced into the bone for its stabilization. The arrow indicates the way to introduce the implant 1 into the humerus bone.

Claims (15)

As a bone implant (1) for stabilizing fractured or non-fractured bone,
The implant comprises an implant body (2) extending along a longitudinal axis (3) from an anterior side (4) to an end side (5), said implant body (2) about said longitudinal axis (3). With an implant width 6 extending vertically, the length of the implant body 2 along the longitudinal axis 3 is at least 5 times the implant width 6, the implant body 2 having at least It has an outer surface divided into a first surface (7) and a second surface (8),
said first surface (7) consists of a holding area (9) extending at least partially over said outer surface;
wherein the implant does not include an extension at the proximal end;
The outer surface includes a plurality of holes 12 having walls around the hole axis 11,
The plurality of apertures 12 are uniformly distributed in an area over 360° centered on the longitudinal axis 3 of the outer surface or the second surface 8, but adjacent to each other in a row. (12) are distributed in rows along the longitudinal axis (3) such that the spacing between them is equal,
Bone implant, characterized in that each of the plurality of holes (12) is not connected by a groove. 2. The method according to claim 1, wherein the implant (1) comprises a bore (10) extending along the longitudinal axis (3) or parallel to the longitudinal axis (3), the bore being the anterior side, A bone implant characterized in that it has at least one opening on the end side or both. The bone implant according to claim 1 or 2, characterized in that the length of the bone implant ranges from 10 mm to 250 mm. 3. Bone implant according to claim 1 or 2, characterized in that the width (6) of the bone implant ranges from 2 mm to 10 mm. 3. The implant (1) according to claim 1 or 2, wherein the implant (1) comprises a first set of holes (12), the hole axes (11a) of the first set of holes (12) orthogonal to the longitudinal axis. Bone implant, characterized in that arranged to be. 3. The implant according to claim 1 or 2, wherein the implant comprises a second set of holes (12), the hole axes (11b) of the second set of holes (12) being relative to the longitudinal axis (3). A bone implant characterized in that it is inclined. 3. Bone implant according to claim 1 or 2, characterized in that the fixation area (9) comprises means for improving fixation of the implant in the bone. 3. The fixing area (9) according to claim 1 or 2, comprising a surface structure in the form of a groove (13), which is uniformly arranged about the longitudinal axis and extends coaxially along the longitudinal axis. Bone implant, characterized in that to do. 3. Bone implant according to claim 1 or 2, characterized in that the fixation area (9) comprises a surface structure in the form of a thread (14) or a ring-shaped groove (15). delete delete delete delete delete delete

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